IRB Process -After IRB Approval [IRBNet Only]

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Save copies of the final approved materials

Submit an amendment

Submit a continuing review application (if required)

Submit any reportable events

Close your study

Create a new package + submit

Save copies of the final approved materials

To be sure you have and use the approved version of materials, the IRB recommends that you go back to the package after approval to download and save all relevant materials, especially consent forms. The consent forms in your approved IRBNet PACKAGE must be used with participants.

To download the materials, please go to the project in IRBNet and click on the title of the project in blue. Then go to the Designer Page and locate the list of Documents in the package. Click on the “paper icon” next to each document to download a copy and save.

You should also download a copy of your approval letter.

To locate your approval letter, please go to the project in IRBNet and click on the title of the project in blue. This should take you to the Project Overview page. On the left-hand side under Project Administration, you should see Reviews. Click on this and you should see the approval letters under Board Documents. Click on the blue text that says Approval Letter for the most recent package to download it.

Submit an amendment

When is an amendment needed?

If you need to make a change to a study that has been approved, the Principal Investigator must submit an amendment application to the IRB.

Any deviation from the approved research protocol must be reviewed by the IRB prior to implementation of those changes. This applies to Exempt, Expedited, and Full Board studies.

If the proposed revisions modify the protocol a great deal, the IRB may request that a new protocol application be submitted. Contact the IRB Office with any questions.

Examples of changes that warrant an amendment:

Adding or removing study personnel
Adding or removing a research site
Updating contact information on a flyer
Changing wording on the previously approved consent form
Revising the study procedures
Revising the study title
Changing the Principal Investigator
Adding or removing a question in your survey/interview
Adding translated versions of study documents (recruitment materials, consent forms)
Adding Letters of Support/Approval from schools, research sites, or community partners

Please note that this is not an exhaustive list. If you are not sure whether a change requires an amendment, please reach out to the IRB Office.

Please note: For projects with expiration dates, the approval of an Amendment Request will not change the expiration date of the protocol. The expiration of IRB Approval will remain the same as determined at the previous Initial IRB Approval or Continuing Review.

What to submit

To submit an amendment, you will need to complete: a) the Amendment Application and b) prepare any materials that have been revised since the initial submission or any new materials that have yet to be approved by the IRB. Submit these materials to the IRB in a new package.

If amending the Consent Form, please update the package number in the footer of the Consent Form to reflect the package number under which this Amendment will be submitted.
If new investigators/researchers will be added to the protocol and will be engaged in human subject research (HSR) activities (interaction with participants and/or identifiable data from participants), IRB Approval is required prior to these members engaging in any HSR activities. All HSR-engaged investigators/researchers must complete appropriate human subjects research training - CITI Basic Human Subjects Training.
- For UMD investigators/researchers, their CITI training should be linked to their User Profile and to the package in IRBNet (see the IRB Training page).
- For external investigators (e.g. people who are not faculty, student, or staff at UMD), the PI may upload a copy of their CITI training (or equivalent) as a Supporting Document.

Submit a continuing review application (if required)

Continuing review applications are required for Full Board projects and a limited number of Expedited projects that require increased oversight. If your project requires a continuing review, there will be an expiration date on the approval letter.

Projects with continuing review that will continue past 8/31/26: Projects expiring after 2/28/26 must first complete the Kuali-IRB transition before a continuing review can be submitted in Kuali-IRB. See the transition timeline resources for more details.

Projects with continuing review that will CLOSE before 8/31/26: If the project must remain open past the expiration date but will CLOSE before 8/31/26, submit the continuing review application in IRBNet. Contact the IRB Office (irb@umd.edu) for the forms.

Submit any reportable events

Reportable events include adverse events, unanticipated problems, and protocol deviations. For more information on what is considered a reportable event, see the Reportable Events and Non-Compliance page.

To submit a reportable event, you will need to complete either the Adverse Event/Unanticipated Problem Report or the Deviation Report, depending on the type of event. Submit the appropriate form to the IRB in a new package.

Close your study

A protocol is eligible for closure if ALL of the following are true:

Data collection is complete
There is no more participant contact (including follow-up interviews, calls, surveys)
The only research activity remaining is analysis of de-identified data
- Information is identifiable if participants can be identified directly or indirectly through identifiers linked to the participants. This includes any key linking participants to pseudonyms/study IDs.

To close your study, you will need to complete the Closure Application Form and submit it in a new package.

Create a new package + submit

What is a new package?

When projects are submitted for the first time, they receive a unique project number. Each time a new submission is made for a single project, you will submit it under the same project number, but the package number will change. For example “123456” is the project number, and “123456-1” is an Initial Application package. If you submitted an Amendment to make a change to that project, the package number for the amendment would be “123456-2”.

Create a new package

To create a new package for an amendment, continuing review, reportable event, or closure report:

Login to irbnet.org and Click MY PROJECTS and click the title of the project you wish to modify.
Click the CREATE NEW PACKAGE button on the left of the screen under the Project Administration heading.
Upload the materials: click DESIGNER to attach the documents required for the submission type.
For each document, click ATTACH NEW DOCUMENT and follow the instructions. Select a Document Type by clicking the blue dropdown arrow.
1. If editing/uploading your consent form (e.g. for an amendment or continuing review), please update the package number in the footer of the Consent Form to reflect the package number under which this package will be submitted and approved. This ensures you are using the most “up-to-date” version of the form.
2. To find the IRBNet package number, go to the MY PROJECTS tab and click on the title of your project. In the PROJECT OVERVIEW page, your IRBNet package number will be listed at the top, next to your project title.

Submit a new package

Have the Principal Investigator sign off on the package.
1. If you are not the Principal Investigator in IRBNet, send them a message by clicking “Send Project Mail” requesting that they review and sign off. Proceed only once you have received email confirmation from IRBNet that they have signed off.
2. If you are the Principal Investigator in IRBNet, Click SIGN THIS PACKAGE under the Project Administration menu and follow the instructions.
  1. Please note that only the Principal Investigator is required to sign off on amendments, continuing reviews, reportable events, and closure reports.
When the PI has signed off, Click SUBMIT THIS PACKAGE.
Select “University of Maryland College Park IRB” in the “Search for Organization” dropdown menu and click Continue.
1. NOTE: Please be careful when selecting where to submit your project as there are two review boards at the University of Maryland, the IRB (human subjects only) and the IACUC (animal research only). Selecting the incorrect board will require your application to be withdrawn and then will need to be resubmitted to the correct board. This will DELAY your REVIEW and APPROVAL.
Finally, select a Submission Type based on the type of application being submitted and click “SUBMIT.”
Click PROJECT OVERVIEW to review what has been sent. Project Status will reflect “Pending Review” status until the review has been completed. If status reads “Work in Progress” you have not submitted the project.

When the IRB receives your submission, the IRB may unlock the package for more information and will inform the investigators of the next steps via IRBNet.